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胎儿血乳酸的即时检测——是时候信赖一种新设备了。

Point-of-care measurement of fetal blood lactate - Time to trust a new device.

作者信息

Wang Mandy, Chua Seng C, Bouhadir Lilain, Treadwell Erin L, Gibbs Emma, McGee Therese M

机构信息

Department of Obstetrics and Gynaecology, Westmead Hospital, Sydney, New South Wales, Australia.

Sydney Medical School Westmead, University of Sydney, Sydney, New South Wales, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2018 Feb;58(1):72-78. doi: 10.1111/ajo.12671. Epub 2017 Jul 31.

DOI:10.1111/ajo.12671
PMID:28758199
Abstract

BACKGROUND

Point-of-care lactate devices are used worldwide for intrapartum decision making. Current practice is often based on Lactate Pro (Arkray) but its imminent product discontinuation necessitates determination of an optimal replacement device.

AIMS

To evaluate the performance of Lactate Pro and two other point-of-care devices, Lactate Pro 2 (Arkray) and StatStrip (Nova Biomedical), and to derive scalp lactate cut-offs equivalent to the current intervention trigger of >4.8 mmol/L.

MATERIALS AND METHODS

Paired umbilical cord arterial and venous blood samples from 109 births were tested on the three point-of-care products (two devices each), cross-compared with the reference method blood gas analyser.

RESULTS

All brands deviate from the blood gas analyser, with Lactate Pro and StatStrip results consistently lower and Lactate Pro 2 consistently higher. Standard deviation from the blood gas analyser was smallest for StatStrip (0.78 mmol/L, cord artery), and largest for Lactate Pro 2 (1.03 mmol/L, cord artery). Within-brand variation exists and is similar for all brands (mean absolute difference on cord artery 0.23-0.30 mmol/L). Equivalent values to the 4.8 mmol/L intervention threshold based on Lactate Pro are 4.9-5.0 mmol/L for StatStrip and 5.3-5.9 mmol/L for Lactate Pro 2, calculated by receiver-operating characteristic analysis.

CONCLUSIONS

StatStrip appears superior to Lactate Pro 2 to replace the original Lactate Pro. Using StatStrip, the 4.8 mmol/L intervention threshold equivalent was 4.9-5.0 mmol/L. The variation in accuracy of point-of-care lactate devices may exceed the small increments (eg <4.2 mmol/L vs >4.8 mmol/L) that guide obstetric decisions.

摘要

背景

即时检测乳酸设备在全球范围内用于分娩期决策。目前的做法通常基于乳酸测定仪(爱科来公司),但其即将停产,因此需要确定一种最佳的替代设备。

目的

评估乳酸测定仪、另外两种即时检测设备(乳酸测定仪2代(爱科来公司)和StatStrip(诺瓦生物医学公司))的性能,并得出与当前>4.8 mmol/L的干预触发值相当的头皮乳酸临界值。

材料与方法

对109例分娩的脐动脉血和脐静脉血配对样本在三种即时检测产品(每种产品两台设备)上进行检测,并与参考方法血气分析仪进行交叉比较。

结果

所有品牌的检测结果均与血气分析仪有偏差,乳酸测定仪和StatStrip的结果始终较低,而乳酸测定仪2代的结果始终较高。与血气分析仪相比,StatStrip的标准差最小(脐动脉为0.78 mmol/L),乳酸测定仪2代的标准差最大(脐动脉为1.03 mmol/L)。各品牌均存在品牌内差异,且所有品牌的差异相似(脐动脉平均绝对差值为0.23 - 0.30 mmol/L)。通过受试者工作特征分析计算得出,基于乳酸测定仪的4.8 mmol/L干预阈值,StatStrip的等效值为4.9 - 5.0 mmol/L,乳酸测定仪2代的等效值为5.3 - 5.9 mmol/L。

结论

StatStrip似乎比乳酸测定仪2代更适合替代原来的乳酸测定仪。使用StatStrip时,等效于4.8 mmol/L的干预阈值为4.9 - 5.0 mmol/L。即时检测乳酸设备的准确性差异可能超过指导产科决策的微小增量(例如<4.2 mmol/L与>4.8 mmol/L)。

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